NCT00546949 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Lønne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Rønning R, Nygaard ØP
Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514-
Lønne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard ØP
Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015 Jan 15;40(2):77-85. doi: 10.109

Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)

Clinical trial NCT00546949 - References